Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2020-01-16
2024-03-31
Brief Summary
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Detailed Description
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Mutation analysis may not only help identify cancer drivers, but they can also provide useful data to predict response to other treatment modalities such as immunotherapies, particularly immune checkpoint blockade. There is published data on liquid biopsy in India from oncology in the field of pulmonary and renal cancers, but these studies have not been done in cirrhosis or in HCC patients.
Objectives In this project we hope to develop a biomarker panel which helps us prognosticate patients and tailor targeted therapy as per their genetic mutation landscape. The treatment options for advanced HCC are limited, and tissue biopsy is not routinely performed.
Methods In this pilot project, we will analyze 30 patients with unresectable hepatocellular carcinoma, ineligible for liver transplantation, who will undergo locoregional therapy in the form of transarterial chemoembolization (TACE) or radioembolization (TARE) for tissue diagnosis of tumor tissue DNA and circulating tumor DNA. We will design personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing will be performed using cell-free DNA and paired primary tumor tissue DNA in order to create a non-invasive liquid biopsy for diagnosis and prognostication of HCC.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Unresectable HCC undergoing locoregional therapy
Patients with unresectable HCC who have no curative option like tumour ablation, resection or transplantation and are being taken for locoregional therapy will be recruited
Cell Free DNA
Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy
Interventions
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Cell Free DNA
Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years of either sex
Exclusion Criteria
* Refractory ascites
* Severe Coagulation disorders prior to the procedure (PTI \<70% and Platelet count \< 80,000/mm3)
* Hepato-Renal syndrome
* Chronic Kidney Disease
* Acute decompensation like Hepatic encephalopathy and variceal bleeding
* Any known malignancy other than HCC
* Life expectancy \< 6 months
18 Years
70 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Madhumita Premkumar
Assistant Professor, Department of Hepatology
Principal Investigators
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Radhika Srinivasan, MD PhD
Role: STUDY_CHAIR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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Postgraduate Institute of Medical Education and Research
Chandigarh, Choose Any State/Province, India
Countries
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Central Contacts
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Harman Dhaliwal, MSc
Role: CONTACT
Facility Contacts
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Madhumita Premkumar
Role: primary
Other Identifiers
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INT/HEP/1078
Identifier Type: -
Identifier Source: org_study_id
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